SAM #26-000806

NIH Seeks Enhanced LEN Adherence Services for HELP Study (Sole Source to University of Maryland Baltimore)

This procurement opportunity is issued by the National Institutes of Health (NIH) Clinical Center for enhanced services supporting the HELP Study on HIV prevention: - Government Buyer: - National Institutes of Health (NIH), Clinical Center - OEMs and Vendors: - University of Maryland Baltimore (sole source service provider) - Products/Services Requested: - Enhanced LEN (long-acting injectable cabotegravir) adherence and retention services for the HELP Study - Design and implementation of adaptive interventions to improve LEN adherence and continuation - Establishment of study nodes in Washington, DC, Baltimore, and West Virginia - Coalition building with local partners for study execution - Unique/Notable Requirements: - Focus on a multi-site, five-year clinical trial using the EPIS implementation science framework - Services are specific to the ongoing HELP Study and require expertise in HIV prevention research and community coalition building - No physical products, part numbers, or other OEMs are specified; the procurement is for specialized research services only

Description

This is a Notice of Intent (NOI). This notice is published in accordance with Federal Acquisition Regulation (FAR) 5.101(a)(1) requiring the dissemination of information regarding proposed contract actions. This is a Notice of Intent to award a sole source, firm-fixed price purchase order under the authority of 41 U.S.C. 253 (c)(1), Only One Responsible Source and No Other Supplies or Service Will Satisfy Agency Requirements and is not a request for quotes. The National Institutes of Health (NIH) intends to negotiate on an other than full and open competition basis with the University of Maryland Baltimore for additional services during Option Year 4 of the Contract 75N90022C00017.

Only one award will be made as a result of this solicitation.  This will be awarded as a firm-fixed price type of contract.

Period of Performance(s) are as follows:

One Year.

An anticipated effective date of September 15, 2026.

Acquisition purpose and objectives:

The scope of activities for this contract shall focus on the “Getting to Zero HIV Transmission Through Enhanced LEN for PrEP (HELP) Study.”   The purpose is to understand LEN uptake, adherence, and retention, and assess an adaptive intervention to improve LEN adherence and continuation.  HELP will be implemented in Washington, DC, Baltimore, Maryland and West Virginia.

The services are:

Complete all activities necessary to design an adaptive intervention for LEN adherence and retention for the HELP multicenter clinical trial during the first 12-18 months of the project.  HELP is a five-year multi-site effectiveness implementation hybrid type 2 randomized controlled trial using the Exploration, Preparation, Implementation, and Sustainment (EPIS) implementation science framework.

Establish HELP study three geographic locations (nodes) that include Washington, DC, Baltimore and West Virginia.  If necessary, node locations may be added or removed in consultation with the COR Through coalition building with partners, design intervention focused on LEN adherence and retention.

THIS IS NOT A SOLICITATION FOR COMPETITIVE QUOTATIONS.  All responsible sources that could provide the required services may submit a capability statement that will be considered by email by the due date and time on the closure of this posting.  All responses received by the closing date of this notice will be considered by the Government.  A determination not to compete this requirement, based upon responses to this notice, is solely within the discretion of the Government.

This notice does not obligate the Government to award a contract or otherwise pay for any information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization's qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted.

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